Pharma Company Has Received Final Approval From United States Food and Drug Administration For Abbreviated New Drug Application
The company has a market cap of over Rs 1 lakh crore and the stock is up by 13 per cent from its 52-week low of Rs 1,310.05 per share.
Cipla Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial. This notification is made in compliance with Regulation 30 and Schedule III Part A Para B of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, as well as the SEBI Circular dated November 11, 2024. The approval was granted on April 10, 2025.
Cipla's Protein-bound Paclitaxel is an AB-rated generic equivalent of Bristol Myers Squibb’s Abraxane® for Injectable Suspension 100 mg/vial. This medication is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer (NSCLC), and metastatic adenocarcinoma of the pancreas. Cipla anticipates launching this product in the United States of America during the first half of the fiscal year 2025-26.
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Cipla Ltd. is a prominent pharmaceutical company engaged in the business of pharmaceuticals, holding a significant market leadership position in India. It ranks as the 3rd largest player in the domestic Rx market and holds the top position in the Respiratory segment, while also being among the top 5 in Urology and Anti-infectives. With a substantial field force of over 7,500 professionals reaching a vast network of healthcare professionals, Cipla boasts a diversified product portfolio encompassing over 1,500 products across more than 50 dosage forms and 65 therapeutic categories, demonstrating its global reach and commitment to introducing new medicines, with 93 product launches.
The company has a market cap of over Rs 1 lakh crore and the stock is up by 13 per cent from its 52-week low of Rs 1,310.05 per share. Investors should keep an eye on this pharma stock.
Disclaimer: The article is for informational purposes only and not investment advice.